BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3207052 · Received June 14, 2013

    Report

    Report Number
    3207052
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 14, 2013
    Manufacturer
    CAREFUSION
    Product Code
    BZR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NO REPORTS OF PATIENT HARM HAS OCCURRED. USERS ARE EXPERIENCING FAILURES OF CONTROL KEYPAD SCREENS. THE FAILURES MAKE CALIBRATION AND SETTING OF ALARMS INOPERABLE. THE FAILURES HAVE BEEN COMPLETE ON SOME UNITS AND INTERMITTENT ON OTHERS. OXYGEN DELIVERY IS NOT AFFECTED JUST THE CALIBRATION AND SETTING OF ALARM FUNCTIONS ARE AFFECTED. MULTIPLE FAILURES HAVE BEEN REPORTED IN THE NICU AND IN OTHER AREAS AS WELL.======================MANUFACTURER RESPONSE FOR AIR-OXYGEN BLENDER, MAXTEC CAREFUSION (PER SITE REPORTER).======================FIELD REP REPLACED SEVERAL KEYPAD SCREENS. UNITS MADE BY CAREFUSION AND PART SUPPLIED BY MAXTEC. APPARENTLY, MAXTEC NOTIFIED CAREFUSION ABOUT CONCERN IN OCT 2012. CAREFUSION TOOK NO ACTION AND DID NOT NOTIFY OUR HOSPITAL. CAREFUSION REP TOLD RESPIRATORY THERAPY DEPT THAT REPLACEMENTS KEYPAD SCREENS WILL BE AVAILABLE "IN A FEW MONTHS". CAREFUSION HAS ASKED THAT WE PROVIDE SERIAL NUMBERS OF ALL AFFECTED UNITS AS CAREFUSION CANNOT TELL WHAT SERIAL NUMBERS MAY BE AFFECTED WITH THIS PROBLEM. BOTH OLDER AND NEW UNITS ARE EXPERIENCING THIS PROBLEM.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ACCURATE AIR-OXYGEN BLENDING THERAPY.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271367 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271368 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271472 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271473 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271474 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271475 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271476 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271477 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271478 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271479 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271480 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271481 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271482 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271483 * MIXER, BREATHING GASES BZR CAREFUSION * *
    271484 * MIXER, BREATHING GASES BZR CAREFUSION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * BLENDERS ARE USED WITH HIGH FLOW OXYGEN IN ADULT I| CUS, MEDSURG UNITS, AND THE NICU